Loading clinical trials...

A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers

An Open Label, Parallel Group, Dose Comparison of Safety and Imaging Characteristics of 111 and 370 MBq (3 and 10 mCi) of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Patients With Alzheimer's Disease (AD)

NCT01565330•Avid Radiopharmaceuticals

View on ClinicalTrials.gov

Summary

This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.

Eligibility

Age

35 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Greater than 50 years of age
•Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
•Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
•History of cognitive decline gradual in onset and progressive over a period of at least 6 months
•35 to 55 years of age, inclusive
•MMSE of 29 or greater

Exclusion Criteria

•Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
•Diagnosis of other dementing / neurodegenerative disease
•Diagnosis of mixed dementia
•Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
•Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
•Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
•Clinically significant psychiatric disease
•History of epilepsy or convulsions
•Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
•Current clinically significant cardiovascular disease
+1 more criteria

Locations (3)

Research Site

West Palm Beach, Florida, United States

Research Site

North East, Maryland, United States

Research Site

Clementon, New Jersey, United States

Key Dates

Start Date

March 1, 2008

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

June 18, 2012

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

florbetapir F 18

DRUG

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

NCT04123314

Depressive SymptomsDepression+2 more

View study

RECRUITINGNA

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

NCT07178210

Alzheimer DiseaseLymphatic Obstruction

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

Longitudinal Early-onset Alzheimer's Disease Study Protocol

A Study of AMDX-2011P in Participants With Alzheimer's Disease